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E006-071

SF - Immunization Devices
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Product Details
Product name
HEATmarker® VVM1
IMD-PQS Code
E006-071
Status
Prequalified
Date of acceptance
01 Nov 2021
Appliance type
E006
Product description
Vaccine Vial Monitor Type 1
Manufacturer
Temptime Corporation, A Zebra Technologies Company
Manufacturer Reference
HEATmarker® VVM1
Country of Manufacture
United States of America
Address
116 American Road, Morris Plains, NJ, 07950, United States
United States of America
Telephone
+1 973 630 6000
Valid until
31 May 2026
Specifications

Product specifications - Main

Mode of operation
Chemical
Activation mechanism
Always active
Fixing mechanism
Adhesive
CE marking
Yes
Time to endpoint at 37°C (days)
1.00
Time to endpoint at 5°C (days)
100.00

Mechanical and electronic devices only

Power source
Passive device
Alarm type
NA
Memory size (Mb)
32.0000000000
Display medium
Color change
Recording medium
Not applicable
Comments
Full labels (typically white or clear liner) and dots (typically brown or clear liner) are made on lightweight litho/paper/film facestock offering exceptional printability and flexibility. The service temperature range for the adhesive is typically -40°F to 160°F, or wider. Liner (can either be PET or coated paper) is designed for label dispensing applications. A clear film-based over-laminate is used for dots (brown liner) for added stability and protection.

Custom solutions including a combination of approved litho/paper/film substrate and over-laminate (if applicable) are available upon request

Price and shipping

Minimum order
500000.00
Incoterms
EXW
Price 1
On request to manufacturer
Year of base price
2021

Quality standard

Quality Standard
ISO 13485;Other
Quality standard (Other)
ISO 9001:2015
Specification Reference
Applicable PQS specification: E006/IN05.4
Applicable PQS VP(s): E006/IN05-VP.4

Verification

Verification Laboratory
0013X00004Ml8OlQAJ
Verification Report Reference
LLTPL/2021/06-01
Product Sites
Temptime Corporation, A Zebra Technologies Company
116 American Road, Morris Plains, NJ, 07950, United States
United States of America
Document Details